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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04673760
Other study ID # DFL Nr. 4887
Secondary ID SNCTP000003820
Status Completed
Phase N/A
First received
Last updated
Start date September 7, 2020
Est. completion date August 1, 2023

Study information

Verified date November 2023
Source Insel Gruppe AG, University Hospital Bern
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The overall objective of this study is to identify whether the systematic anticipation of highly structured specialized palliative home care into primary care influences the quality of care and care utilization. Quality of care focusses on the sense of security of patients and family caregivers, satisfaction with care of patients, family caregivers, general practitioners, home care nurses and specialized palliative care nurses, and availability and access to advanced directives. Health care utilization focus on the number of hospitalizations and the length of hospital stays.


Description:

The University Center for Palliative Care from the Inselspital Bern conducts this monocentric mixed-methods controlled study and is responsible for informed consent. Data consists of questionnaires of patients, their family caregivers, general practitioners, home care nurses and if involved specialized palliative home care nurses. Patients and their family caregivers will fill out baseline questionnaires and follow-up questionnaires at 2, 8, 16 and 24 weeks. Patient follow-up will end if the patient dies or the study ends. Family caregivers will be asked to fill out a questionnaire two months after the patient's death. General practitioners, home care nurses and specialised palliative home care nurses will fill out questionnaires after the patient's death or at the end of the study. Patient survival data will be collected from administrative health data after the end of the study. Additionally, a nested qualitative study with semi-structured qualitative interviews with patients, family caregivers and care providers will provide an in-depth understanding of preferences, needs, experiences from this phase of life.


Recruitment information / eligibility

Status Completed
Enrollment 149
Est. completion date August 1, 2023
Est. primary completion date April 10, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Patients inclusion criteria: - 18 years or older - Able to read and understand German - Able to fill out questionnaires with only minimal assistance - Live in the catchment area of SPHC - Positive screening on the palliative care screening tools - Expected survival time of approximately six months or less - Have a GP (or GP medical substitute) - Registered with Spitex care - Wish to live at home as long as possible (no plans for long term nursing home uptake) - Written informed consent Patients exclusion criteria: - Planned discharged from hospitals to institutions (e.g. other hospitals, rehabilitations, nursing homes) - Live permanently in nursing homes - Cognitive impairments that make it impossible to follow the study (e.g. psychological disorders, dementia, loss of judgement). Family caregivers inclusion criteria: - 18 years or older - Able to read and understand German - Familiar with the care situation patient - Written informed consent Specialized palliative home care team: - Provide care in German speaking part of canton Bern - 24/7-availability of specialized palliative care - Specialized palliative care team including nurses and consulting physician with specialized palliative care certification.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Specialized palliative home care
Specialist palliative home care teams will initiate care as usual, including managing a systematic and collaborative process of advance care planning with patients, family caregivers, GPs and SPITEX nurses using the "Betreuungsplan", information packages and regular case meetings. The GP was additionally provided with educational palliative care information by the study team.

Locations

Country Name City State
Switzerland University Hospital Inselspital Bern Bern

Sponsors (3)

Lead Sponsor Collaborator
Insel Gruppe AG, University Hospital Bern Swiss National Science Foundation, University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Other Health care utilization Measured by questionnaire From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively).
Other Health care costs Measured by administrative health care data From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively).
Other Sense of security of family caregivers Measured by questionnaire From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively).
Other Satisfaction with care of family caregivers Measured by questionnaire FAMCARE-2 Scale. 17 questions on care with answers ( Likert-type scale 1 to 5) ranging from "very satisfied with care" to "very dissatisfied with care". From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively).
Other Satisfaction with care of home care nurses Measured by questionnaire From the date of baseline measurement of patient to study completion, an average of 6 months, or shorter if patient deceases
Other Performance Status of patient Measured by questionnaire , ECOG Scale of performance status.Grading 1 to 4 and higher score indicates lower performance status. From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively).
Other Quality of life of patient Measured by questionnaire Functional Assessment of Chronic Illness Therapy - Palliative Care 14 Item Version (FACIT-Pal-14). (5 point Likert-type scale) From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively).
Other Therapeutic alliance between patients and their home care team Measured by questionnaire The Human Connection Scale (THC) measures the extent to which patients felt a sense of mutual understanding, caring, and trust with their GP, (specialized palliative) home care nurses ( Likert-type scale 1 to 5) From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively).
Primary Sense of security of patients Measured by questionnaire Sense of Security in Care - Patients' Evaluation (SEC-P), This questionnaire has 3 subscales namely, the Care Interaction scale; the Identity scale and the Mastery scale. Higher score indicate a higher level of sens of security at home of the patient. From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively).
Secondary Number of patients who define advance directives Measured by questionnaire From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively).
Secondary Access to advance directives of the patients for the ambulant care providers Measured by questionnaire From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively).
Secondary Satisfaction with care of patient Measured by questionnaire Modified FAMCARE Scale P16. 16 Questions on care with answers (Likert-type scale 1 to 5) ranging from "very satisfied with care" to "very dissatisfied with care" From 2 months before the date of baseline measurement (retrospectively), to six months after the baseline measurement (prospectively).
Secondary Satisfaction with care of GP Measured by questionnaire From date of baseline measurement of patient to study completion, an average of 6 months, or shorter if patient deceases
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